CN111683615A - 具有球状形状射频(rf)消融电极的球囊导管 - Google Patents

具有球状形状射频(rf)消融电极的球囊导管 Download PDF

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CN111683615A
CN111683615A CN201880082448.9A CN201880082448A CN111683615A CN 111683615 A CN111683615 A CN 111683615A CN 201880082448 A CN201880082448 A CN 201880082448A CN 111683615 A CN111683615 A CN 111683615A
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C.T.贝克勒
A.戈瓦里
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Abstract

本发明提供了一种医疗器械，该医疗器械包括轴、可膨胀球囊和射频(RF)消融电极。轴被构造用于插入患者的身体中。可膨胀球囊联接到轴的远侧端部。RF消融电极设置在球囊的外表面上并且具有远侧边缘，该远侧边缘被构造成减小从该远侧边缘发射的RF电场的电场角梯度。

Description

具有球状形状射频(RF)消融电极的球囊导管
技术领域
本发明整体涉及医疗探头，具体地讲，涉及球囊导管。
背景技术
各种已知的导管设计具有装配在其远侧端部处的可膨胀射频消融球囊。例如，美国专利申请公开2014/033393描述了心脏消融导管及使用方法。在一些实施方案中，导管在可扩展隔膜的内部包括至少一个照相机，其用于使消融手术可视化。在一个实施方案中，电极设置在可膨胀球囊上。电极被构造并定位成当球囊膨胀时将消融射频能量传递到组织。电极或电极组可基于其形状在视觉上被识别。例如，电极组可以是圆形、椭圆形、六边形、矩形、正方形等。
又如，美国专利申请公开2010/0204560描述了一种组织电极组件，该组织电极组件包括隔膜，该隔膜被构造成形成能够在患者体内部署的可扩展可适形的主体。该组件还包括柔性电路，该柔性电路被定位在隔膜的表面上并且包括至少一个基底层、至少一个绝缘层和至少一个平面传导层。导电电极覆盖柔性电路的至少一部分以及隔膜表面未被柔性电路覆盖的部分，其中导电电极在其自身上与隔膜可折叠成递送构象，该递送构象具有适于将组件微创递送至患者的直径。电极的形状和图案可改变。电极的表面积、形状和图案可影响所施加的能量的量和所形成的消融线。本文考虑的各种电极图案和电极形状包括但不限于圆形、矩形、八边形和多边形。
发明内容
本发明的一个实施方案提供了一种医疗器械，其包括轴、可膨胀球囊和射频(RF)消融电极。轴被构造用于插入患者的身体中。可膨胀球囊联接到轴的远侧端部。RF消融电极设置在球囊的外表面上并且具有远侧边缘，该远侧边缘被构造成减小从该远侧边缘发射的RF电场的电场角梯度。
在一些实施方案中，电极包括朝向远侧边缘逐渐变窄的细长主体节段以及连接到主体节段的最远端并且比最远端处的主体节段宽的远侧端部节段。在一些实施方案中，电极的远侧边缘具有球状形状，该球状形状具有至少给定的曲率半径。在一个实施方案中，通过减小电场角梯度，远侧边缘被构造成减少电极上的炭化沉积物。
根据本发明的实施方案，还提供了一种用于制造医疗器械的方法，该方法包括在可膨胀球囊的外表面上设置射频(RF)消融电极，该射频消融电极具有远侧边缘，该远侧边缘被构造成减小从该远侧边缘发射的RF电场的电场角梯度。可膨胀球囊联接到被构造用于插入患者的身体中的轴。
结合附图，通过以下对本发明的实施方案的详细描述，将更全面地理解本发明，其中：
附图说明
图1是根据本发明的实施方案的基于导管的消融系统的示意性图解，该系统包括射频(RF)消融球囊；
图2是根据本发明的实施方案的消融球囊的示意性图解，该消融球囊包括球状形状RF消融电极；并且
图3是根据本发明的实施方案的比较在RF消融电极的远侧边缘处产生的电场梯度的示意性图解。
具体实施方式
概述
在下文中描述的本发明的实施方案提供一种RF消融球囊，该球囊包括被设计成减少消融的不利影响的电极，诸如由于过度的电场梯度引起的组织或血液的炭化。
消融期间组织或血液的炭化是非常不希望的副作用。RF消融中遇到的一个问题是电极周围的组织炭化，这产生一种称为“滚降”(阻抗突然增加)的现象，其中电极周围的组织增大其电阻并随之增大电路阻抗。因此，电流循环停止并且不再对组织产生损伤。
通常，炭化还将电极表面的一部分从良好导体转变成不良导体，这可能导致消融电流急剧下降。如上所述，此类下降将限制消融组织的深度(也限制在其它后续位置的深度，其中组织本身未炭化，但使用中的电极至少部分地被烧焦物覆盖)，因此降低了消融手术的效率。此外，在罕见情况下，炭化可能导致血栓栓塞并发症(即，血液栓塞的血栓症)，这可能后续导致严重的临床结果，诸如中风。
尽管例如通过组织冷却和使用冲洗进行局部血液稀释来努力消除炭化，但在RF消融电极的远侧端部(即，远侧边缘)周围仍存在明显的炭化，其中电极的边缘(即，电极轮廓)具有小曲率半径。
在本公开中，估计原因是系统性的：由于此类电极的导电边缘是恒定电势
Figure BDA0002547458390000032
的线，因此电场
Figure BDA0002547458390000031
应在沿着边缘的每个点处垂直于电极边缘。电极远侧端部的急弯曲边缘导致场线相对于彼此以大角度发散。因此，在急弯曲线处出现较大的场梯度。当穿过组织或血液时，过大的场梯度可能导致炭化。
在本发明的一些实施方案中，装配在导管的远侧端部处的消融球囊包括具有扩大的倒圆远侧边缘的RF消融电极。即，不是通常朝向远侧连续变窄并且具有尖锐远侧端部的电极，本发明所公开的电极的端部是具有相对大曲率半径的球状圆形区域。
本发明所公开的包括具有扩大的倒圆远侧边缘的电极的RF消融球囊可减少由与电极远侧边缘处的小曲率半径相关联的高电场梯度引起的组织炭化。通过减少组织炭化，本发明所公开的RF消融球囊可减少RF球囊消融手术的潜在严重临床副作用。另外，避免炭化也可减少可靠性问题并延长电极寿命。
系统描述
图1是根据本发明的实施方案的基于导管的消融系统20的示意性图解，该系统包括RF消融球囊40。系统20包括导管21，其中导管的轴22的远侧端部穿过护套23而插入躺在工作台29上的患者28的心脏26中。导管21的近侧端部连接到控制台24。在本文所述的实施方案中，导管21可用于任何合适的治疗目的和/或诊断目的，诸如心脏26中的组织的电感测和/或消融。
医师30通过使用靠近导管的近侧端部的操纵器32操纵轴22来将轴22的远侧端部导航至心脏26中的目标位置，以及/或者使轴的远侧端部相对于护套23偏转。在轴22的插入期间，球囊40由护套23保持在塌缩构型中。通过将球囊40包含在塌缩构型中，护套23还用于使目标位置沿途的血管创伤最小化。
控制台24包括：处理器41，通常为通用计算机，具有合适的前端；和接口电路38，用于接收来自导管21的信号，以及用于经由导管21对心脏26进行治疗，并用于控制系统20的其它部件。处理器41通常包括通用计算机，该通用计算机以软件编程以执行本文描述的功能。该软件可通过网络以电子形式被下载到计算机，例如或者其可另选地或另外地设置和/或存储在非临时性有形介质(诸如磁存储器、光存储器或电子存储器)上。
图1所示的示例性构型是完全为了使概念清楚而选择的。可使用其它系统部件和设置类似地应用本发明所公开的技术。例如，系统20可包括其它部件并执行非心脏消融治疗。
具有球状形状RF电极的球囊导管
图2是根据本发明的实施方案的消融球囊40的示意性图解，该消融球囊包括球状形状RF消融电极42。如图所示，设置在基板44上的电极42在其远侧端部处包括倒圆边缘50中的每一者。
如图所示，倒圆(即球状)边缘50增大了电极在其远侧端部处的曲率半径，否则将趋于变窄(如虚线52所示)并潜在地产生较高的局部电场。换句话讲，给定的消融电极42包括(i)朝向电极的远侧边缘逐渐变窄的细长主体节段，以及(ii)连接到主体节段的最远端并且比最远端处的主体节段宽的远侧端部节段。
图2所示的示例性例证完全是为了概念清晰而选择的。远侧端部的曲率的其它设计是可能的，例如椭圆形或各种倒圆形状的组合。
图3是根据本发明的实施方案的比较在RF消融电极的远侧边缘处产生的电场梯度的示意性图解。图的左侧所示的电极是具有相对尖锐端部的假设常规电极。根据本发明的实施方案，图的右侧所示的电极包括具有增大曲率半径的端部。
如图3所例示的，电极42的边缘上的位置62之间(或位置60之间)的大小电场梯度分别与法线68(或70)与位置62(或60)处的电极边缘之间的角度成比例。
如图所示，球状边缘处的角度θ2小于公共边缘处的对应角度θ1。因此，相对于曲率52的增大曲率50用于减小角电场梯度。
图3所示的示例性例证完全是为了概念清晰而选择的。远侧端部的曲率的其它设计是可能的，以降低电极42的远侧边缘处的角电场梯度。一个另选示例是椭圆形远侧边缘或具有可变曲率的远侧边缘，以便例如减轻局部过度炭化，即，在电极的远侧边缘上的特定位置处的过度炭化。
尽管本文所述的实施方案主要针对肺静脉隔离，但本文所述的方法和系统也可用于其它应用，诸如耳鼻喉或神经内科手术。
因此应当理解，上面描述的实施方案以举例的方式被引用，并且本发明不限于上文特定示出和描述的内容。相反，本发明的范围包括上文描述的各种特征的组合和子组合以及它们的变型和修改，本领域的技术人员在阅读上述描述时将会想到该变型和修改，并且该变型和修改并未在现有技术中公开。以引用方式并入本专利申请的文献被视为本申请的整体部分，不同的是如果这些并入的文献中限定的任何术语与本说明书中明确或隐含地给出的定义相冲突，则应仅考虑本说明书中的定义。

Claims (7)

1.一种医疗器械，包括：
轴，所述轴用于插入患者的身体中；
可膨胀球囊，所述可膨胀球囊联接到所述轴的远侧端部；和
射频(RF)消融电极，所述射频消融电极设置在所述球囊的外表面上并且具有远侧边缘，所述远侧边缘被构造成减小从所述远侧边缘发射的RF电场的电场角梯度。
2. 根据权利要求1所述的医疗器械，其中所述电极包括：
朝向所述远侧边缘逐渐变窄的细长主体节段；以及
连接到所述主体节段的最远端并且比所述最远端处的所述主体节段宽的远侧端部节段。
3.根据权利要求1所述的医疗器械，其中所述电极的所述远侧边缘具有球状形状，所述球状形状具有至少给定的曲率半径。
4.根据权利要求1所述的医疗器械，其中通过减小所述电场角梯度，所述远侧边缘被构造成减少所述电极上的炭化沉积物。
5. 一种用于制造医疗器械的方法，所述方法包括：
在可膨胀球囊的外表面上设置射频(RF)消融电极，所述射频消融电极具有远侧边缘，所述远侧边缘被构造成减小从所述远侧边缘发射的RF电场的电场角梯度；以及
将所述可膨胀球囊联接到被构造用于插入患者的身体中的轴。
6. 根据权利要求5所述的方法，其中所述电极包括：
朝向所述远侧边缘逐渐变窄的细长主体节段；以及
连接到所述主体节段的最远端并且比所述最远端处的所述主体节段宽的远侧端部节段。
7.根据权利要求5所述的方法，其中所述电极的所述远侧边缘具有球状形状，所述球状形状具有至少给定的曲率半径。
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